So the first question is that as time goes on and FDA tries to impose all of these new requirements on foreign suppliers, will the rest of the world tolerate it?
Glen Burnie, MD (PRWEB) May 03, 2012
FDAImports.com Founder and CEO, Benjamin England, recently spoke at the Food and Drug Law Institute’s (FDLI) Annual Conference on FSMA and imports. During the presentation, “How FSMA Changed the Game on Imports,” Mr. England discussed, along with leading FDA lawyers and industry and FDA officials, FSMA elements that affect imported foods and international trade, including the Foreign Supplier Verification Program (FSVP), the Voluntary Qualified Importer Program (VQIP), various challenges to the international supply chain and the many false presumptions about trade built into the amendment. During Mr. England’s presentation, and the extended question and answer session afterward, he addressed many false assumptions regarding imported foods, food safety, FDA’s view and understanding of trade, and consumer perception issues, such as the recent “pink slime” debacle.
USA Losing its Foothold?
“When the FSMA was first enacted, we were stating within a month that the sky was not falling and that it would take years for FDA to get to the regulations, even if they met their timing obligations,” stated England. “Take seafood HACCP as an example. Many years after FDA first created the HACCP requirements for seafood [referring to when England was an FDA compliance officer] we were still writing Warning Letters to companies with no enforcement to speak of because virtually no one was implementing it correctly. Even after the FSMA regulations are issued there will be comment periods, redrafting and then an enforcement lag that will take several additional years.” Mr. England cited the recent Yum! Brands quarterly earnings report to illustrate how the USA is losing its lead as the world leader of consumption. “The majority of Yum! Brand’s recent revenue figures did not come from the USA market but from China,” said Mr. England. “So the first question is that as time goes on and FDA tries to impose all of these new requirements on foreign suppliers, will the rest of the world tolerate it?”
Mr. England also pointed out that emerging FSMA regulations could leave small and mid-sized businesses unable to compete with larger food companies. “The costs to small and mid-sized importers will likely become severe in coming years, regardless of any exemptions that FDA might hand out to them. These companies simply don’t have the relationships with foreign suppliers necessary to implement the statutory language. They’re the real job-makers, not the big companies. As a result I expect to see consolidation in the food industry. This will cost U.S. jobs, reduce competition, and produce more very large food companies, which is not necessarily better when it comes to food safety.”
Mr. England frequently presents at FDLI events and webinars as well as with other organizations and partners on topics related to FDA regulation, FSMA, FDA detentions, import alerts and compliance.
FDAImports.com is an FDA consulting firm helping U.S. and foreign companies navigate through and meet complex FDA regulations for marketing and importing foods, dietary supplements, drugs, cosmetics and medical devices. Benjamin L. England, Founder and CEO, is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Contact: Jon Barnes, (410) 740-3403 or pr(at)fdaimports.com.